Agency classClass IOur severity:Severe FDA (Drugs)·D-337-2013·Announced 2013-05-22

Mojo nights SUPREME Capsules Recalled for Undeclared Active Ingredients

Performance Plus Marketing, Inc. is recalling Mojo nights SUPREME Capsules because the product was marketed without an approved NDA/ANDA and may contain undeclared sildenafil, tadalafil, and analogues.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric. The presence of undeclared active pharmaceutical ingredients in an unapproved drug constitutes a significant health risk.

Plain-English summary

Performance Plus Marketing, Inc. is recalling Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs. The product is distributed by Mojo Health in Pompano Beach, FL, and carries the UPC 610585435915. The recall covers 70,000 capsules distributed nationwide. The specific lot number is 01MJS0712, with an expiration date of 07/15.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The source text states that the product may contain undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients, which makes them unapproved drugs.

Consumers who have purchased Mojo nights SUPREME Capsules with the specified lot number and expiration date should stop using the product. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the product.

The recalled product

Product: Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Unapproved Sexual Enhancer
Hazard: undeclared-ingredients
unapproved-drug
Affected units: 70,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot# 01MJS0712
Exp 07/15.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Performance Plus Marketing, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Performance Plus Marketing, Inc.

See all →

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